RedHill Biopharma Ltd. (NASDAQ; RDHL) (TASE: RDHL) 宣布已经在美国启动二期临床试验，评估12毫克BEKINDA™ 治疗腹泻型肠道易激综合征患者的安全性和疗效。
BEKINDA™ (RHB-102)介绍：
BEKINDA™ 是受专利保护的、昂丹司琼缓释（24小时）口服药片制剂。 BEKINDA™治疗急性肠胃炎和慢性胃炎的三期临床试验正在美国进行中，预计将在2016年下半年发布试验结果。 BEKINDA™已经启动治疗腹泻型肠道易激综合征的二期试验。 RedHill还在欧洲寻求将BEKINDA™用于预防化疗和放射疗法引起的恶心呕吐的上市许可，目前正在等待欧盟国家的反馈意见，以决定是否需要展开进一步的临床和化学、制造与控制方面工作。
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家总部位于以色列的新兴生物医药公司，致力于开发和商业化治疗炎症性疾病和肠胃疾病（包括癌症）的处于后期临床试验阶段、专有的、口服的小分子药。公司目前的产品管线包括：(i) RHB-105 -治疗幽门螺杆菌感染的口服混合药，首个三期试验获得成功；(ii) RHB-104 -治疗克罗恩病的口服混合药，正在进行首个三期试验以及治疗多发性硬化症的二a期概念验证试验；(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司琼口服药片制剂，正在美国进行治疗急性肠胃炎和慢性胃炎的三期试验，以及治疗腹泻型肠易激综合征的二期试验；(iv) RHB-106 -肠道准备药物胶囊，已经授权给Salix Pharmaceuticals Ltd.；(v) YELIVA™ (ABC294640 ) -口服SK2选择性抑制剂，是首创新药，靶向为多种肿瘤、炎症性和胃肠道适应症，已经启动治疗难治的/恶化的扩散性的大B细胞淋巴瘤的一/二期试验；(vi) MESUPRON® – 处于二期试验阶段的uPA抑制剂口服胶囊，是首创新药，靶向为胃肠和其他实体瘤；(vii) RP101 – Hsp27抑制剂口服药片，是处于二期试验阶段的首创新药，靶向为胰腺癌和其他胃肠癌，RedHill拥有该药物的收购选择权；(viii) RIZAPORT™ (RHB-103) -利扎曲坦口服薄膜制剂，用于治疗急性偏头痛，正在与美国食品药品监督管理局讨论新药申请，2015年10月获准在德国上市；以及(ix) RHB-101 -心血管药物卡维地洛日服一次的口服药片制剂。
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects, ” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation , risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate develop ment efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to establish and maintain corporate collaborations; (vi) the Company’s ability to acquire products approved for marketing in the US that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical st udies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Secu rities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 25, 2016. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
